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Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral LIdocaine 1%

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ClinicalTrials.gov Identifier: NCT02215057
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hassan Mohamed Ali, Cairo University

Brief Summary:

General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were performed deep into the orbit, but it is now accepted that peribulbar injections using shorter needles are safer. In the last few years, continuing concern over the rare but serious complications of sharp needle blocks has led to increasing interest in the use of sub-Tenon`s blocks utilizing a blunt cannula 1-5.

Even with the use of blunt canulae sub-Tenon`s block, serious problems can still occur, especially in myopic patients with large axial length. In phakic IOL surgery,topical anesthesia has been used successfully for years. Topical anesthesia has several advantages over regional infiltrative techniques, the foremost of which is the abolition of any risk of inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient satisfaction, but still there are some patients that experience intraoperative discomfort.

In this study we compared topical anesthesia alone with topical anesthesia plus intracameral lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be because of the direct action of lidocaine on the iris, which in turn causes muscle relaxation.


Condition or disease Intervention/treatment Phase
Other Iris and Ciliary Body Disorders Drug: topical anesthesia Drug: topical anesthesia plus intracameral lidocaine 1% Not Applicable

Detailed Description:

were enrolled in this study after obtaining approval from the institutional ethical committee and written patients consent. We estimated our sample size based on a method described by Lerman. A sample size of 45 will detect a 20% difference between each group; this will give an alpha value of 0.05 with a power of 80%. With a fall-out rate of approximately 19%, we decided to increase the number of patients in each group to 51.All patients were assessed and only those who were deemed suitable for topical and intracameral lidocaine 1% were included in the study.Very anxious patients were omitted from the study.

We are planning a study of matched sets of patients receiving the experimental and control treatments with 1 matched control(s) per experimental subject. Prior data indicate that the probability of a treatment failure among controls is 0.05 and the correlation coefficient for exposure between matched experimental and control subjects are 0.1. If the true odds ratio for failure in experimental subjects relative to control subjects is 0.1, we will need to study 51 experimental subjects with 1 matched control(s) per experimental subject to be able to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The Type I error probability associated with this test of this null hypothesis is 0.3.

All the operations were done by one surgeon (SE).Patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops and Group 2 (the second eye) received topical anesthesia plus intracameral lidocaine 1% at the start of sugery through the 3.00 mm corneal incision. Before giving the anesthetics, a peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial blood pressure were monitored.Topical anesthesia was done with 2% tetracaine local anesthetic drops .

Pain was estimated by the patient using a simple pain score: no pain =0; that does not interfere with the surgical technique, discomfort=1; the surgical technique is performed with difficulty, pain=2; the surgeon is unable to continue the surgical technique. The scoring was done during different stages of surgery: lid retraction while inserting a speculum, tolerance to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates, irrigation and aspiration (I/A) of viscoelastic, and peripheral iridectomy. The surgical technique was performed through a clear corneal 3.0 mm tunnel incision, followed by sodium hyaluronate injection, ICL/toricICL implantation(V4B,STAAR,California,USA) and unfolding, tucking of trailing footplates then side port incision and tucking of leading footplates, MIOSTAT 0.01% (Alcon,Texas,USA) injection, then peripheral iridectomy .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral Lidocaine 1% in Patients Undergoing Implantable Collamer Lens (ICL) Procedure
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 2
topical anesthetic drops patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops
Drug: topical anesthesia
topical anesthetic drops and Group 2
Other Name: LOCAL ANESTHESIA

Experimental: Group 1
received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%'
Drug: topical anesthesia
topical anesthetic drops and Group 2
Other Name: LOCAL ANESTHESIA

Drug: topical anesthesia plus intracameral lidocaine 1%
received topical anesthesia plus intracameral lidocaine 1%
Other Name: received topical anesthesia plus intracameral lidocaine 1%




Primary Outcome Measures :
  1. PAIN [ Time Frame: 15 MINUTES ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any age
  • calm patient
  • agreed

Exclusion Criteria:

  • co agulopathy anxious refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215057


Locations
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Saudi Arabia
Magrabi Aseer ,KSA
Khamis Mushayt, West, Saudi Arabia, 516
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Hassan M Ali, Lecturer Cairo University

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Responsible Party: Hassan Mohamed Ali, lecturer of anesthesia, Cairo University
ClinicalTrials.gov Identifier: NCT02215057    
Other Study ID Numbers: 1479
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Keywords provided by Hassan Mohamed Ali, Cairo University:
topical anesthesia
intracameral lidocaine
implantable collamer lens
Additional relevant MeSH terms:
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Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action